Comparison of satisfaction, pain and other complication in proximal and distal ulnar nerve local anesthesia in patients undergoing angiography via palmar artery
Determination and comparison of satisfaction, pain and other complications in two methods of local anesthesia in distal and proximal ulnar nerve in patients undergoing trans-palmar coronary artery angiography
Design
This study is a single-blind randomized clinical trial with parallel randomized groups on 54 patients who are candidates for angiography referred to Shahid Chamran Heart Center, Isfahan University of Medical Sciences.
simple randomization method and trial phase 2-3 was performed
After selecting patients, satisfaction, pain and complications such as
vascular spasm, paresthesia were evaluated
Settings and conduct
In Shahid Chamran Heart Center, local anesthetic injection was done in the distal and proximal ulnar nerve and a comparison of satisfactions, pain, and other complications was performed. Single blindness(analyzer) was performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- All patients who are candidates for angiography referred to Chamran Hospital
Isfahan University of Medical Sciences
2- Patient consent to participate in this study
Exclusion criteria:
1- Having Raynaud's syndrome
2. Having vascular disorders of the upper extremities
3. Carpal tunnel syndrome
4 - Having sensory-motor disorders that affect the ulnar and median nerves
Given
5. Chronic tenosynovitis
Intervention groups
They are placed under local anesthesia by proximal method.
In this method, 1% lidocaine is used as subcutaneous 3-5 ml
It is located in the area 2 cm proximal to the internal ulnar epicondyle
Salcus will be injected at a 45 degree angle. The control group will receive the anesthetic at the wrist (distal).
Main outcome variables
Selecting the appropriate anesthesia method in performing trans-palmar coronary angiography
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181228042155N3
Registration date:2020-09-05, 1399/06/15
Registration timing:retrospective
Last update:2020-09-05, 1399/06/15
Update count:0
Registration date
2020-09-05, 1399/06/15
Registrant information
Name
Mohammad Kermani-Alghoraishi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3345 9614
Email address
sm.kermani@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
2019-09-11, 1398/06/20
Actual recruitment end date
2020-07-22, 1399/05/01
Trial completion date
2020-08-22, 1399/06/01
Scientific title
Comparison of satisfaction, pain and other complication in proximal and distal ulnar nerve local anesthesia in patients undergoing angiography via palmar artery
Public title
Comparison of proximal and distal ulnar nerve local anesthesia in patients undergoing angiography via palmar artery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All pationts candidated for tranns palmar coronary angiography thah addmited to Shahid chamran hospital
Patient consent to participate in this study
Exclusion criteria:
Raynaud's syndrome
Upper extremity vascular disorders
Having sensory-motor disorders that affect the ulnar nerves
Chronic tenosynovitis
Existence of any arthritis or joint disease involving the elbow and proximal forearm
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method using a table of random numbers
Blinding (investigator's opinion)
Single blinded
Blinding description
Given that the patient and physician know the location of the anesthetic injection, blindness is only about collecting and analyzing data.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar jarib st
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-09-07, 1398/06/16
Ethics committee reference number
IR.MUI.MED.REC.1398.320
Health conditions studied
1
Description of health condition studied
Evaluation of appropriate anesthesia in coronary angiography through palmar artery
ICD-10 code
I25
ICD-10 code description
Chronic ischemic heart disease
Primary outcomes
1
Description
Pain
Timepoint
One hour, four hours, twelve hours and one month after the procedure
Method of measurement
Visual analogue scale
2
Description
Satisfaction
Timepoint
One hour, four hours, twelve hours and one month after the procedure
Method of measurement
Questionnaire
3
Description
Vascular spasm
Timepoint
One hour, four hours, twelve hours and one month after the procedure
Method of measurement
Clinical and clinical observation
4
Description
Ulnar nerve damage
Timepoint
One hour, four hours, twelve hours and one month after the procedure
Method of measurement
Physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group; patients are placed under local proximal anesthesia. In this method, 1% lidocaine in the form of subcutaneous (3-5 ml) is used, which is injected in the proximal 2 cm area into the internal epicondyle and ulnarsalcus (at a 45 degree angle). Anesthesia is done with an insulin syringe
Category
Treatment - Other
2
Description
Control group:for Patients, local anesthesia was done at distal part of ulnar nerve
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid chamran hospital
Full name of responsible person
Fereshteh-Farazandeh
Street address
Salman farsi st,moshtagh
City
Isfahan
Province
Isfehan
Postal code
8166173414
Phone
+98 31 3261 1406
Email
Dr.farazande85@Gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farshad roghani
Street address
Salman farsi,moshtagh
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3261 1406
Email
roghani_eint@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Kermani-Alghoraishi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Salman farsi st,moshtagh
City
Isfahan
Province
Isfehan
Postal code
8166173414
Phone
+98 31 3261 1406
Email
Sm.kermani@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fereshteh Farazandeh
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Salman farsi st, moshtagh
City
Isfahan
Province
Isfehan
Postal code
8166173414
Phone
+98 31 3261 1406
Email
dr.farazandeh85@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Kermani-Alghoraishi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Salman farsi st,moshtagh
City
Isfahan
Province
Isfehan
Postal code
81661731414
Phone
+98 31 3261 1406
Email
Sm.kermani@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Unidentifiable data on the main outcome of the study will be provided to researchers upon individual or academic request
When the data will become available and for how long
Six months to one year after the publication of the article - according to the rules of the journal
To whom data/document is available
Academic and scientific researchers
Under which criteria data/document could be used
For use in similar studies to complete research
From where data/document is obtainable
corresponding authors email of published article
Email of Dr Mohammad Kermani-Alghoraishi : sm.kermani@med.mui.ac.ir
Email of Dr Farshad Roghani-Dehkordi : roghani_int@yahoo.com
What processes are involved for a request to access data/document
After the article was published, according to the rules of the journal, the applicant can request the documents by an email to the corresponding author. Response time is between 1 to 4 weeks depending on the type of request.